Application 213478
- Type
- NDA
- Sponsor
- NOBELPHARMA CO., LTD.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HYFTOR | SIROLIMUS | GEL; TOPICAL | 0.2% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73683-101 | HYFTOR | sirolimus | Nobelpharma America, LLC | NDA | Current |
| 73683-101 | HYFTOR | sirolimus | NOBELPHARMA AMERICA, LLC | NDA | Current |
| 73683-101 | HYFTOR | sirolimus | Nobelpharma America, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71095 | ORIG | 2022-05-19 |
| 70600 | ORIG | 2022-03-25 |
| 70590 | ORIG | 2022-03-23 |